After seven years of legal wranglings, the Supreme Court on Monday will deliver its verdict on the contentious patenting status of Glivec, an expensive anti-cancer drug, manufactured by pharmaceutical major Novartis.
After being denied protection on the molecule in India, Novartis challenged a key provision in the Indian Patent Act that inhibits protection of intellectual property rights on variants of an existing molecule unless there is significant therapeutic improvement.
The court verdict may also touch upon the price of leukaemia drug Glivec and other expensive drugs whose cheap generic versions are available in the market.
Glivec (imatinib mesylate) is the salt form of a previously known anti-cancer drug, sold in India for a price of Rs 1, 20,000 ($2,400) per patient per month. Indian firms sell its generic versions for Rs 8,000– 10,000 ($160–200) per patient per month. Since the original molecule was developed before 1995, it does not have a product patent in India.
Because of the World Trade Organisation requirement, India in 1995 agreed to allow patenting of pharmaceutical products and processes under Trade Related Aspects of Intellectual Property Rights (TRIPS) within 10 years.
While amending the patent law to meet this requirement in 2005, the government introduced Section 3(d) of the Indian Patent Act, prohibiting patents on variants of existing compounds that do not show enhanced efficacy. It was done ostensibly to take care of public health taking advantage of a TRIPS provision.
The pharmaceutical industry argues this clause establishes an unacceptably high barrier to patenting and limits incentive for research. But many others defend the law as a way to promote public health by enabling more drugs—particularly those who are hugely expensive—to be produced as generics.
Citing 3(d), Indian Patent Office in 2006 rejected Novartis’ application for a patent on the crystalline form of the basic compound in Glivec.
The company not only challenged the decision in Chennai High Court but also moved a separate petition questing the constitutional validity of the section 3(d). The High Court ruled against Novartis in 2007 and two years later Intellectual Property Appellate Board turned down Novartis plea on the patent cover for Glivec. Novartis moved the apex court in 2009.
The Supreme Court’s judgment could very well be a watershed verdict setting the ground rule on patent protection of many new medicines, which may only have an incremental benefit from its predecessor.